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Regulatory Submissions, Information, and Document Management Forum


Session 5 Track 4: Following the Sun: Regulatory Ops in Global Organization

Session Chair(s)

Christian A. Buckley, MBA, RAC

Christian A. Buckley, MBA, RAC

  • Associate Director, Regulatory Affairs
  • Astellas, United States
Maintaining quality submissions with an ever-growing portfolio requires an organization to utilize global publishing resources and adjust to regional workload fluctuations. Regulatory Operations can add value over the success of Regulatory Affairs and the entire company beyond just technical expertise on electronic submissions. Global submissions must be “first time right” and regulatory information must be easily and quickly available “right at your fingertips”. The current trend of globalization is an opportunity for Regulatory Operations to develop into a key position for worldwide integral and comprehensive Regulatory information and submission management.

The following areas will be discussed:
  • Challenges for cooperation among a worldwide workforce
  • Data quality framework and options to embed continuous data quality control
  • Regulatory process owner – continuous improvement beyond compliance
  • Submissions need project leaders, not super heroes
  • Explore offshoring of regulatory operations as an effective solution to increasing operational demands.
Learning Objective : 1) Describe impact of Global Work Share and Offshoring to balance submission workload between publishing locations in a large organization. 2) Discuss the development of processes and standards that were executed to develop Work Share program.

Speaker(s)

Timm  Pauli

From Regulatory Operations to Integrated Regulatory Information and Submission Management

Timm Pauli

  • Sr. Director, eSubmission Services, Head of Regulatory Operations
  • PharmaLex GmbH, Germany
Mary Anne Potok

Cross-Continent Competence: Successes and Struggles with Offshore Regulatory Operations Support

Mary Anne Potok

  • Technical Manager, Regulatory Operations
  • MMS Holdings Inc., United States
Jennifer  Costello

Global Work Share – A Case Study of Utilizing Workshare Between Groups to Balance Workload

Jennifer Costello

  • Associate Director, Global Dossier Management
  • Bristol-Myers Squibb, United States